- Merck & Co. (Rahway, NJ)
- …of our existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate ... processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and… more
- Insmed Incorporated (Columbus, OH)
- …to the highest standards The Therapeutic Specialist will possess a high clinical aptitude and seasoned experience in a portfolio environment to ensure the voice ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...Company policy and procedures Demonstrate high ethical and performance standards with all business contacts in order to maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership ... study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the ... Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards , data quality rules and data governance ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi... data governance activities (eg developing and implementing data standards )3 or more years' Experience working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... Participates in the development of, and ensures adherence to, our company's clinical data management procedures. Interacts with staff across sites, countries,… more
- Merck & Co. (North Wales, PA)
- …trial environment.Required Experience and Skills: Experience with study data standards CDISC (SDTM)Experience in SAS and clinical programming.Knowledge and ... to external vendors and partners, and keeping current with industry submission data standards .The incumbent will be responsible for continuous improvement of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Merck & Co. (North Wales, PA)
- …establishing technical and cross functional business needs between our company's Business (eg Global Data Management & Standards (GDMS), Biostatistics & ... company's IT data hub - InForm, DMW, Clinical Data Repository (CDR), Site Management Authoring...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Eisai, Inc (Nutley, NJ)
- …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... The incumbent will assume a crucial role within the Global Value & Access (GV&A) team, responsible for leading...statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs...EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …( Clinical Operations, Clinical Biomarkers, Precision Medicine, etc.) for establishing data collection, data standards and data cleaning needs ... to external data acquisition, and establishes external data standards , reinforces adherence to existing ...standard data collection practices preferred- 7+ years Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stakeholders ( Clinical Operations, Clinical Biomarkers, QCP, etc.) for establishing data collection, data standards and data cleaning needs ... in line with agreed upon EFTs, eDTS, DS External Data Standards and Contract/SOW.Promotes Daiichi Sankyo values...is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This ... compliance across clinical study safety reporting and activities. Global Clinical Study Start-Up Documentation: Reviews all...the project and/or study level as it relates to data capture and reporting. Establishes EDC standards … more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... Lead and provide statistical support for related drug/vaccine projects in Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …impacting the respective clinical programs.Help to ensure in collaboration with Global Development Operations (GDO) ( Global Clinical Operations / ... all vendor managed business setups with the objective of achieving the highest data quality standards , full adherence to patient's rights and well-being and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. ... all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
